JET BLUE BITE FAST 50 ml 6491

GUDID 07630243635757

Dent4You AG

Silicone dental impression material
Primary Device ID07630243635757
NIH Device Record Key704531c3-a1b5-4135-b295-4a42f5cf501f
Commercial Distribution StatusIn Commercial Distribution
Brand NameJET BLUE BITE FAST 50 ml
Version Model Number6491
Catalog Number6491
Company DUNS480152811
Company NameDent4You AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107630243635757 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-22
Device Publish Date2026-01-14

Devices Manufactured by Dent4You AG

07640397422042 - StatClean Ultrasonic Cleaner2026-03-19 Ultrasonic Cleaner
07640397422189 - HYDRIM 112W G4+ Instrument Washer2026-02-19 Automated instrument washer
17640397422339 - HIP Cleaning Solution2026-02-19 Hydrim Cleaning Solution with Instrument Protection. For the Hydrim 112W G4+ Instrument Washer.
07640397422349 - HYDRIM 112W G4+ Instrument Washer2026-02-19 Automated instrument washer (Loaner)
07640397422356 - HYDRIM 112W G4+ Instrument Washer2026-02-19 Automated instrument washer (Refurbished)
07630243600595 - BRILLIANT Crios2026-02-18 BRILLIANT Crios Bleach LT 14 CEREC
07630243600601 - BRILLIANT Crios2026-02-18 BRILLIANT Crios A1 LT 14 CEREC
07630243600618 - BRILLIANT Crios2026-02-18 BRILLIANT Crios A2 LT 14 CEREC

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.